Dapagliflozin and Metformin Hydrochloride

Orange BookUNIISPLATC A10BK

Last synced from FDA National Drug Code directory (United States) on June 3, 2026

Identification

ManufacturerMacleods Pharmaceuticals Limited

CountryUS (United States)

ATC codeA10BK

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 5

ndc11
3334240806
3 BLISTER PACK in 1 CARTON (33342-408-06) / 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (33342-408-66)
ndc11
3334240807
30 TABLET, EXTENDED RELEASE in 1 BOTTLE (33342-408-07)
ndc11
3334240809
60 TABLET, EXTENDED RELEASE in 1 BOTTLE (33342-408-09)
ndc11
3334240810
90 TABLET, EXTENDED RELEASE in 1 BOTTLE (33342-408-10)
ndc11
3334240815
500 TABLET, EXTENDED RELEASE in 1 BOTTLE (33342-408-15)

Annotations

UNII (FDA Substance ID)

1ULL0QJ8UC

DAPAGLIFLOZIN

RxCUI 1488564

Orange Book

A211559

ABABABAB

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "1ULL0QJ8UC",
    "rxcui": "1488564",
    "inchikey": "JVHXJTBJCFBINQ-ADAARDCZSA-N",
    "display_name": "DAPAGLIFLOZIN",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "52a778e7-6044-2049-e063-6294a90aa0b7": {
      "match": "brand_token",
      "title": "DAPAGLIFLOZIN TABLET, FILM COATED [AVKARE]",
      "spl_version": "2",
      "published_date": "2026-05-28"
    }
  },
  "productid": "33342-408_7d575ca8-9c1f-469d-a341-34daf2f036dd",
  "productndc": "33342-408",
  "dosage_form": "TABLET, EXTENDED RELEASE",
  "orange_book": {
    "appl_no": "211559",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "5MG;500MG",
        "product_no": "001",
        "approval_date": "Apr 6, 2026"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "5MG;1GM",
        "product_no": "002",
        "approval_date": "Apr 6, 2026"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "10MG;500MG",
        "product_no": "003",
        "approval_date": "Apr 6, 2026"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "10MG;1GM",
        "product_no": "004",
        "approval_date": "Apr 6, 2026"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE",
  "proprietary_name": "Dapagliflozin and Metformin Hydrochloride",
  "active_ingred_unit": "mg/1; mg/1",
  "application_number": "ANDA211559",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Dapagliflozin and Metformin Hydrochloride",
  "start_marketing_date": "20260406",
  "active_numerator_strength": "5; 1000"
}

Related drugs

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